MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number 1000462HJ

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous unspecified lesion.A balance heavyweight (bhw) guide wire was being advanced to the lesion using a radial access; however, when the guide wire got to the shoulder there was resistance and could not advance any further.An unspecified catheter was then advanced over the guide wire and it also met resistance so the devices were removed as a single unit.Outside the anatomy it was noted that the tip of the guide wire had separated and remained in the anatomy.The tip was removed by a surgical procedure.There was no clinically significant delay in the procedure.The patient is doing well.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary:the device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The separation was confirmed.The failure to advance and difficult to position could not be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The hi torque guide wires instructions for use states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to filing the initial mdr, the following additional information was provided: the bmw guide wire was used for an off-label indication.

Manufacturer Narrative

(b)(4).The device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The separation was confirmed.The failure to advance and difficult to position could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to filing the final mdr, the following information was received: the physician did not use the stent off-label, it was just radial access.

• Brand Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6281776
• MDR Text Key: 65896552
• Report Number: 2024168-2017-00719
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1000462HJ
• Device Lot Number: 6101471
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention